Recall Z-1071-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1071-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-10-11, terminated 2020-05-07. It names one FDA 510(k) clearance: K103145. Product: TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.. Reason: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-11
Terminated: 2020-05-07
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K103145 — HAMMERLOC TM TIBIAL FIXATION DEVICEBiomet Sports Medicine·cleared 2011-02-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

Reason for recall

Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.

Data sourced from openFDA. This site is unofficial and independent of the FDA.